STATEMENT OF WORK HCV genotype Analysis Platform (GenMark eSensor XT-8) SCOPE Purchase reagents and consumables for the detection of HCV genotypes. Pricing for Item: eSensor HCVg Direct Test Kit (RUO) 24 Cartridges in the Kit Item Number: MT008102 Pricing for Base + 4 Option Years if available. GENERAL REQUIREMENTS 1) The vendor will provide the facility with reagents, controls, disposables, and any consumable parts necessary for analyses. All components of the system must function as an in-vitro diagnostic test for HCV genotyping. 2) The C&A requirements do not apply and the Security Accreditation Package is not required. EQUIPMENT FUNCTIONALITY 1) System shall have a design that allows for preparation and analysis with minimal reagent waste. 2) System shall have a design that removes the possibility of sample carryover. 3) System shall have positive sample identification to reduce possible sources of error/delay and to improve laboratory efficiency. INSTALLATION AND VALIDATION The vendor provided installation/set-up including: installation/set-up, correlation studies (evaluation/comparison data sufficient to satisfy CAP standards), normal range studies, staff training, in-services to laboratory personnel and clinicians, and assisted with any methodology problems and questions. This service is available during regular office hours on a 5 days/week basis. SERVICE AND MAINTENANCE 1) Instrument support service provides assistance with troubleshooting and repair of the analyzer. On-site service is available Monday through Friday during regular business hours (8am-5pm). 2) The vendor provides a twenty-four hour/seven-day service hotline with technical support. 3) The vendor provides a preventative maintenance schedule to include timely scheduled vendor preventative maintenance visits as required. 4) Vendor provides standard and routine software and hardware upgrades to the equipment hardware and operating systems, without additional charge to the Government (e.g. upgrades that correct or improve either the mechanical operations or software of the system and would keep the instrument performing optimally). 5) Vendor reports no maintenance required of users TRAINING: The vendor provided in-depth training for the use of the analyzer for at least two individuals.

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